U.S. patent application number 13/793638 was filed with the patent office on 2013-10-24 for ocular implants for delivery into an anterior chamber of the eye.
The applicant listed for this patent is Andrew T. Schieber, John Wardle. Invention is credited to Andrew T. Schieber, John Wardle.
Application Number | 20130281907 13/793638 |
Document ID | / |
Family ID | 49380785 |
Filed Date | 2013-10-24 |
United States Patent
Application |
20130281907 |
Kind Code |
A1 |
Wardle; John ; et
al. |
October 24, 2013 |
Ocular Implants for Delivery into an Anterior Chamber of the
Eye
Abstract
An ocular implant adapted to be disposed within Schlemm's canal
of a human eye with a body extending along a curved longitudinal
central axis in a curvature plane, a first strut on one side of the
implant and a second strut on an opposite side of the implant, the
circumferential extent of the first strut with respect to the plane
of curvature being greater than the circumferential extent of the
second strut with respect to the plane of curvature. The invention
also includes methods of using the implant.
Inventors: |
Wardle; John; (San Clemente,
CA) ; Schieber; Andrew T.; (Irvine, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Wardle; John
Schieber; Andrew T. |
San Clemente
Irvine |
CA
CA |
US
US |
|
|
Family ID: |
49380785 |
Appl. No.: |
13/793638 |
Filed: |
March 11, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61635104 |
Apr 18, 2012 |
|
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|
Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61F 9/00781
20130101 |
Class at
Publication: |
604/8 |
International
Class: |
A61F 9/007 20060101
A61F009/007 |
Claims
1. An ocular implant adapted to be disposed within Schlemm's canal
of a human eye and configured to support Schlemm's canal in an open
state, the ocular implant comprising: a body extending along a
curved longitudinal central axis in a curvature plane, the body
comprising a central channel bordered by an opening, first and
second frames and a spine interposed between the first and second
frames, the spine having a circumferential extent, the body having
dimensions adapted to be fit within Schlemm's canal; each frame
comprising a first strut on one side of the implant and a second
strut on an opposite side of the implant, the first strut extending
circumferentially beyond the circumferential extent of the spine on
the one side of the implant and the second strut extending
circumferentially beyond the circumferential extent of the spine on
the other side of the implant, the circumferential extent of the
first strut with respect to the plane of curvature being greater
than the circumferential extent of the second strut with respect to
the plane of curvature.
2. The ocular implant of claim 1 wherein the body has a curved
resting shape.
3. The ocular implant of claim 1 wherein the implant is adapted to
bend preferentially in a preferential bending direction.
4. The ocular implant of claim 3 wherein the preferential bending
direction is in the curvature plane.
5. The ocular implant of claim 3 wherein the preferential bending
direction is not in the curvature plane.
6. The ocular implant of claim 1 wherein the circumferential extent
of the first strut beyond the circumferential extent of the spine
on the one side of the implant is greater than the circumferential
extent of the second strut beyond the circumferential extent of the
spine on the other side of the implant.
7. The ocular implant of claim 1 wherein the spine comprises a
first spine, the implant further comprising a third frame and a
second spine interposed between the second and third frames, the
second spine having a circumferential extent, the third frame
comprising a first strut on one side of the implant and a second
strut on an opposite side of the implant, the first strut and
second strut of the third frame each having a circumferential
extent greater than the circumferential extent of the second spine,
the circumferential extent of the first strut with respect to the
plane of curvature being greater than the circumferential extent of
the second strut with respect to the plane of curvature.
8. The ocular implant of claim 7 wherein the first, second and
third frames are substantially identical.
9. The ocular implant of claim 7 wherein the first and second
spines are substantially identical.
10. The ocular implant of claim 7 wherein the first spine is
adapted to bend preferentially in a first bending direction, and
the second spine is adapted to bend preferentially in a second
bending direction different from the first bending direction.
11. The ocular implant of claim 1 wherein the plane of curvature
intersects the spine.
12. The ocular implant of claim 11 wherein the spine extends
circumferentially in substantially equal amounts from the plane of
curvature.
13. The ocular implant of claim 1 wherein the opening comprises an
elongated opening extending longitudinally along the frames and the
spine.
14. The ocular implant of claim 13 further comprising a second
opening bordered by the first and second struts of the first frame
and a third opening bordered by the first and second struts of the
second frame.
15. A method of treating glaucoma in a human eye, the method
comprising: inserting a cannula through a cornea of the eye into an
anterior chamber of the eye; placing a distal opening of the
cannula in communication with Schlemm's canal of the eye; moving an
ocular implant out of the cannula through the opening and into
Schlemm's canal, the ocular implant comprising a central channel
and first and second landing surfaces, the first and second landing
surfaces being disposed on opposite sides of the central channel;
and engaging a scleral wall of Schlemm's canal with the first and
second landing surfaces such that reaction forces on the first and
second landing surfaces from engagement with the scleral wall are
substantially equal.
16. The method of claim 15 wherein the engaging step comprises
engaging the scleral wall of Schlemm's canal with the first and
second landing surfaces without substantially twisting the ocular
implant.
17. The method of claim 15 wherein the implant has a resting shape
forming a curve, the method further comprising orienting the
implant curve with a curve of Schlemm's canal.
18. The method of claim 15 wherein the cannula is curved at a
distal end, the method further comprising orienting the cannula for
tangential delivery of the implant from the cannula into Schlemm's
canal.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C.
.sctn.119 of U.S. Patent Appl. No. 61/635,104, filed Apr. 18, 2012,
the disclosure of which is incorporated by reference.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
FIELD
[0003] The present invention relates generally to devices that are
implanted within the eye. More particularly, the present invention
relates to systems, devices and methods for delivering ocular
implants into the eye.
BACKGROUND
[0004] According to a draft report by The National Eye Institute
(NEI) at The United States National Institutes of Health (NIH),
glaucoma is now the leading cause of irreversible blindness
worldwide and the second leading cause of blindness, behind
cataract, in the world. Thus, the NEI draft report concludes, "it
is critical that significant emphasis and resources continue to be
devoted to determining the pathophysiology and management of this
disease." Glaucoma researchers have found a strong correlation
between high intraocular pressure and glaucoma. For this reason,
eye care professionals routinely screen patients for glaucoma by
measuring intraocular pressure using a device known as a tonometer.
Many modern tonometers make this measurement by blowing a sudden
puff of air against the outer surface of the eye.
[0005] The eye can be conceptualized as a ball filled with fluid.
There are two types of fluid inside the eye. The cavity behind the
lens is filled with a viscous fluid known as vitreous humor. The
cavities in front of the lens are filled with a fluid know as
aqueous humor. Whenever a person views an object, he or she is
viewing that object through both the vitreous humor and the aqueous
humor.
[0006] Whenever a person views an object, he or she is also viewing
that object through the cornea and the lens of the eye. In order to
be transparent, the cornea and the lens can include no blood
vessels. Accordingly, no blood flows through the cornea and the
lens to provide nutrition to these tissues and to remove wastes
from these tissues. Instead, these functions are performed by the
aqueous humor. A continuous flow of aqueous humor through the eye
provides nutrition to portions of the eye (e.g., the cornea and the
lens) that have no blood vessels. This flow of aqueous humor also
removes waste from these tissues.
[0007] Aqueous humor is produced by an organ known as the ciliary
body. The ciliary body includes epithelial cells that continuously
secrete aqueous humor. In a healthy eye, a stream of aqueous humor
flows out of the anterior chamber of the eye through the trabecular
meshwork and into Schlemm's canal as new aqueous humor is secreted
by the epithelial cells of the ciliary body. This excess aqueous
humor enters the venous blood stream from Schlemm's canal and is
carried along with the venous blood leaving the eye.
[0008] When the natural drainage mechanisms of the eye stop
functioning properly, the pressure inside the eye begins to rise.
Researchers have theorized prolonged exposure to high intraocular
pressure causes damage to the optic nerve that transmits sensory
information from the eye to the brain. This damage to the optic
nerve results in loss of peripheral vision. As glaucoma progresses,
more and more of the visual field is lost until the patient is
completely blind.
[0009] In addition to drug treatments, a variety of surgical
treatments for glaucoma have been performed. For example, shunts
were implanted to direct aqueous humor from the anterior chamber to
the extraocular vein (Lee and Scheppens, "Aqueous-venous shunt and
intraocular pressure," Investigative Ophthalmology (February
1966)). Other early glaucoma treatment implants led from the
anterior chamber to a sub-conjunctival bleb (e.g., U.S. Pat. No.
4,968,296 and U.S. Pat. No. 5,180,362). Still others were shunts
leading from the anterior chamber to a point just inside Schlemm's
canal (Spiegel et al., "Schlemm's canal implant: a new method to
lower intraocular pressure in patients with POAG?" Ophthalmic
Surgery and Lasers (June 1999); U.S. Pat. No. 6,450,984; U.S. Pat.
No. 6,450,984). More recent glaucoma treatment implants are
designed to be advanced into and placed in Schlemm's canal. (See,
e.g., U.S. Pat. No. 7,740,604; US 2011/0009958.)
SUMMARY OF THE DISCLOSURE
[0010] The present invention relates to methods and devices for
treating glaucoma. In particular, the invention relates to an
implant designed to extend from the anterior chamber of a human eye
into Schlemm's canal and to support the tissue of Schlemm's canal
to support flow of aqueous humor from the anterior chamber into
Schlemm's canal to the outflow channels communicating with
Schlemm's canal.
[0011] In one aspect, the invention provides an ocular implant
adapted to be disposed within Schlemm's canal of a human eye and
configured to support Schlemm's canal in an open state. The ocular
implant has a body extending along a curved longitudinal central
axis in a curvature plane, the body having a central channel
bordered by an opening, first and second frames and a spine
interposed between the first and second frames, the spine having a
circumferential extent, the body having dimensions adapted to be
fit within Schlemm's canal; each frame comprising a first strut on
one side of the implant and a second strut on an opposite side of
the implant, the first strut extending circumferentially beyond the
circumferential extent of the spine on the one side of the implant
and the second strut extending circumferentially beyond the
circumferential extent of the spine on the other side of the
implant, the circumferential extent of the first strut with respect
to the plane of curvature being greater than the circumferential
extent of the second strut with respect to the plane of curvature.
In some embodiments, the body has a curved resting shape.
[0012] The implant may be adapted to bend preferentially in a
preferential bending direction. In some embodiments, the
preferential bending direction is in the curvature plane, and in
some embodiments the preferential bending direction is not in the
curvature plane.
[0013] In some embodiments, the circumferential extent of the first
strut beyond the circumferential extent of the spine on the one
side of the implant is greater than the circumferential extent of
the second strut beyond the circumferential extent of the spine on
the other side of the implant.
[0014] In embodiments in which the implant also has a third frame
and a second spine interposed between the second and third frames,
the second spine having a circumferential extent, the third frame
having a first strut on one side of the implant and a second strut
on an opposite side of the implant, the first strut and second
strut of the third frame each having a circumferential extent
greater than the circumferential extent of the second spine, the
circumferential extent of the first strut with respect to the plane
of curvature may be greater than the circumferential extent of the
second strut with respect to the plane of curvature. The first,
second and third frames may be substantially identical, and the
first and second spines may be substantially identical. In some
embodiments, the first spine is adapted to bend preferentially in a
first bending direction, and the second spine is adapted to bend
preferentially in a second bending direction different from the
first bending direction.
[0015] In some embodiments, the plane of curvature intersects the
spine. The spine may extend circumferentially in substantially
equal amounts from the plane of curvature.
[0016] In some embodiments, the opening is an elongated opening
extending longitudinally along the frames and the spine. The
implant may also have a second opening bordered by the first and
second struts of the first frame and a third opening bordered by
the first and second struts of the second frame.
[0017] Another aspect of the invention provides a method of
treating glaucoma in a human eye. The method may include the
following steps: inserting a cannula through a cornea of the eye
into an anterior chamber of the eye; placing a distal opening of
the cannula in communication with Schlemm's canal of the eye;
moving an ocular implant out of the cannula through the opening and
into Schlemm's canal, the ocular implant having a central channel
and first and second landing surfaces, the first and second landing
surfaces being disposed on opposite sides of the central channel;
and engaging a scleral wall of Schlemm's canal with the first and
second landing surfaces such that reaction forces on the first and
second landing surfaces from engagement with the scleral wall are
substantially equal.
[0018] In some embodiments, the engaging step includes the step of
engaging the scleral wall of Schlemm's canal with the first and
second landing surfaces without substantially twisting the ocular
implant.
[0019] In some embodiments, the implant has a resting shape forming
a curve, and the method includes the step of orienting the implant
curve with a curve of Schlemm's canal.
[0020] In some embodiments, the cannula is curved at a distal end,
and the method includes the step of orienting the cannula for
tangential delivery of the implant from the cannula into Schlemm's
canal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a stylized representation of an exemplary medical
procedure in accordance with this detailed description.
[0022] FIG. 2 is an enlarged perspective view further illustrating
delivery system 70 and eye 20 shown in the previous figure.
[0023] FIG. 3A is a stylized perspective view illustrating the
anatomy of an eye. FIG. 3B is a stylized perspective view depicting
the surface that defines the anterior chamber of the eye shown in
FIG. 3A.
[0024] FIG. 4 is a stylized perspective view showing Schlemm's
canal and an iris of the eye shown in the previous figure.
[0025] FIG. 5A is a photographic image showing a histology slide
HS. Histology slide HS of FIG. 5A was created by sectioning and
staining tissue from a cadaveric eye. An ocular implant was
implanted in Schlemm's canal of the cadaveric eye prior to
sectioning. FIG. 5B is a perspective view of the ocular implant
used to generate the slide image shown in FIG. 5A.
[0026] FIG. 6A is a stylized line drawing illustrating histology
slide HS shown in the previous figure. FIG. 6B is a simplified
cross-sectional view illustrating the eye from which the histology
sample was taken. FIG. 6A and FIG. 6B are presented on a single
page to illustrate the location of the histology sample relative to
other portions of the eye.
[0027] FIG. 7A is a stylized line drawing showing an ocular implant
residing in a section of an eye including Schlemm's canal. FIG. 7B
is a section view showing the ocular implant prior to insertion
into Schlemm's canal of the eye. FIG. 7C is a perspective view
showing the ocular implant being inserted into Schlemm's canal.
[0028] FIG. 8A is a stylized line drawing showing an ocular implant
according to the detailed description residing in a section of an
eye including Schlemm's canal. FIG. 8B is a section view showing
the ocular implant of Figure A prior to insertion into Schlemm's
canal of the eye. FIG. 8C is a perspective view showing the ocular
implant of FIGS. 8A and 8B being inserted into Schlemm's canal.
[0029] FIG. 9 is a perspective view showing the ocular implant of
FIG. 7.
[0030] FIG. 10 is an additional perspective view showing the ocular
implant of FIG. 8.
[0031] FIG. 11A is a stylized perspective view showing a conical
surface that is sized and positioned so as to intersect a
hemispherical surface in two places. FIG. 11B is a stylized
perspective view showing an ocular implant disposed inside a
chamber defined by a hemispherical surface.
[0032] FIG. 12A, FIG. 12B and FIG. 12C are plan views of the ocular
implant of FIG. 8 created using multiview projection.
[0033] FIG. 13A is a plan view showing the ocular implant of FIG.
8. FIG. 13B is an enlarged section view taken along section line
B-B shown in FIG. 13A. FIG. 13C is an additional enlarged section
view taken along section line C-C shown in FIG. 13A.
[0034] FIG. 14A is a perspective view showing the ocular implant of
FIG. 8. A first plane and a second plane are shown intersecting the
ocular implant in FIG. 14A. FIG. 14B is a plan view further
illustrating the second plane shown in FIG. 14A.
[0035] FIG. 15A, FIG. 15B and FIG. 15C are multi-plan views of a
yet another ocular implant in accordance with the detailed
description.
[0036] FIG. 16A is a plan view showing the ocular implant of FIG.
15. FIG. 16B is an enlarged section view taken along section line
B-B shown in FIG. 16A. FIG. 16C is an additional enlarged section
view taken along section line C-C shown in FIG. 16A.
[0037] FIG. 17A is a perspective view showing the ocular implant of
FIG. 15. A first, second and third planes are shown intersecting
the ocular implant in FIG. 17A. FIG. 17B is a plan view further
illustrating the second plane shown in FIG. 17A. FIG. 17C is a plan
view further illustrating the third plane shown in FIG. 17A.
[0038] FIG. 18A is an additional perspective view of the ocular
implant shown in the previous figure. The ocular implant 300 of
FIG. 18A includes a distal-most spine and a distal-most frame. In
the exemplary embodiment of FIG. 18A, the distal-most frame
comprises a first strut and a second strut. FIG. 18B is a stylized
isometric view showing the profiles of the distal-most spine, the
first strut and the second strut shown in FIG. 18A.
[0039] FIG. 19A and FIG. 19B are perspective views showing distal
portions of the ocular implant of FIG. 8 and the ocular implant of
FIG. 15, respectively.
[0040] FIG. 20 is a perspective view showing yet another exemplary
ocular implant in accordance with the detailed description.
[0041] FIG. 21 is a stylized perspective view showing Schlemm's
canal encircling an iris. For purposes of illustration, a window is
cut through a first major side of Schlemm's canal in
[0042] FIG. 21. Through the window, an ocular implant can be seen
residing in a lumen defined by Schlemm's canal.
[0043] FIG. 22 is an enlarged cross-sectional view further
illustrating Schlemm's canal SC shown in FIG. 21.
DETAILED DESCRIPTION
[0044] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The drawings, which are not
necessarily to scale, depict illustrative embodiments and are not
intended to limit the scope of the invention.
[0045] FIG. 1 is a stylized representation of an exemplary medical
procedure in accordance with this detailed description. In the
exemplary procedure of FIG. 1, a physician is treating an eye 20 of
a patient P. In the exemplary procedure of FIG. 1, the physician is
holding a hand piece of a delivery system 70 in his or her right
hand RH. The physician's left hand LH is holding the handle H of a
gonio lens 23 in the exemplary procedure of FIG. 1. It will be
appreciated that some physicians may prefer holding the delivery
system hand piece in the right hand and the gonio lens handle in
the left hand.
[0046] During the exemplary procedure illustrated in FIG. 1, the
physician may view the interior of the anterior chamber using gonio
lens 23 and a microscope 25. Detail A of FIG. 1 is a stylized
simulation of the image viewed by the physician. A distal portion
of a cannula 72 is visible in Detail A. A shadow-like line
indicates the location of Schlemm's canal SC which is lying under
various tissue (e.g., the trabecular meshwork) that surround the
anterior chamber. A distal opening of cannula 72 is positioned near
Schlemm's canal SC of eye 20.
[0047] Methods in accordance with this detailed description may
include the step of advancing the distal end of cannula 72 through
the cornea of eye 20 so that a distal portion of cannula 72 is
disposed in the anterior chamber of the eye. Cannula 72 may then be
used to access Schlemm's canal of the eye, for example, by piercing
the wall of Schlemm's canal with the distal end of cannula 72. A
distal opening of cannula 72 may be placed in fluid communication
with a lumen defined by Schlemm's canal. The ocular implant may be
advanced out of the cannula and into Schlemm's canal. Insertion of
the ocular implant into Schlemm's canal may facilitate the flow of
aqueous humor out of the anterior chamber of the eye.
[0048] FIG. 2 is an enlarged perspective view further illustrating
delivery system 70 and eye 20 shown in the previous figure. In FIG.
2, cannula 72 of delivery system 70 is shown extending through a
dome-shaped wall 90 of eye 20. The dome shaped wall includes the
cornea 36 of eye 20 and scleral tissue that meets the cornea at a
limbus of the eye. A distal portion of cannula 72 is disposed
inside the anterior chamber AC defined by the dome-shaped wall 90.
In the embodiment of FIG. 2, cannula 72 is configured so that a
distal opening of cannula 72 can be placed in fluid communication
with Schlemm's canal. In the embodiment of FIG. 2, the distal end
of cannula 72 is curved so that the distal opening of the cannula
can be inserted at least partially into Schlemm's canal along a
tangential approach.
[0049] In the embodiment of FIG. 2, an ocular implant is disposed
in a passageway defined by cannula 72. Delivery system 70 includes
a mechanism that is capable of advancing and retracting the ocular
implant along the length of cannula 72. The ocular implant may be
placed in Schlemm's canal of eye 20 by advancing the ocular implant
through the distal opening of cannula 72 while the distal opening
is in fluid communication with Schlemm's canal.
[0050] FIG. 3A is a stylized perspective view illustrating a
portion of eye 20 discussed above. Eye 20 includes an iris 30
defining a pupil 32. In FIG. 3A, eye 20 is illustrated in a
cross-sectional view created by a cutting plane passing through the
center of pupil 32. Eye 20 includes a dome-shaped wall 90 having a
surface 92 defining an anterior chamber AC. In FIG. 3A, surface 92
is shown having a generally hemispherical shape. Dome-shaped wall
90 of eye 20 comprises a cornea 36 and scleral tissue 34. The
scleral tissue 34 meets the cornea 36 at a limbus 38 of eye 20.
Additional scleral tissue 34 of eye 20 surrounds a posterior
chamber PC filled with a viscous fluid known as vitreous humor. A
lens 40 of eye 20 is located between anterior chamber AC and
posterior chamber PC. Lens 40 is held in place by a number of
ciliary zonules 42.
[0051] Whenever a person views an object, he or she is viewing that
object through the cornea, the aqueous humor, and the lens of the
eye. In order to be transparent, the cornea and the lens can
include no blood vessels. Accordingly, no blood flows through the
cornea and the lens to provide nutrition to these tissues and to
remove wastes from these tissues. Instead, these functions are
performed by the aqueous humor. A continuous flow of aqueous humor
through the eye provides nutrition to portions of the eye (e.g.,
the cornea and the lens) that have no blood vessels. This flow of
aqueous humor also removes waste from these tissues.
[0052] Aqueous humor is produced by an organ known as the ciliary
body. The ciliary body includes epithelial cells that continuously
secrete aqueous humor. In a healthy eye, a stream of aqueous humor
flows out of the eye as new aqueous humor is secreted by the
epithelial cells of the ciliary body. This excess aqueous humor
enters the blood stream and is carried away by venous blood leaving
the eye.
[0053] With reference to FIG. 3A, it will be appreciated that
Schlemm's canal SC is disposed inside anterior chamber AC.
Schlemm's canal SC is a tube-like structure that encircles iris 30.
In the illustration of FIG. 3A, the cutting plane passing through
the center of pupil 32 has also passed through Schlemm's canal.
Accordingly, two laterally cut ends of Schlemm's canal SC are
visible in the cross-sectional view of FIG. 3A. In a healthy eye,
aqueous humor flows out of anterior chamber AC and into Schlemm's
canal SC. Aqueous humor exits Schlemm's canal SC and flows into a
number of collector channels. After leaving Schlemm's canal SC,
aqueous humor is absorbed into the venous blood stream and carried
out of the eye.
[0054] Because of the position of Schlemm's canal SC within the
anterior chamber AC, a Schlemm's canal access cannula inserted
through the cornea 36 and anterior chamber AC is likely to approach
the plane of Schlemm's canal at an approach angle that is greater
than zero. Thus, for example, when using a curved cannula (such as
the one shown in FIG. 2) to deliver an implant into Schlemm's
canal, the plane of curvature of the cannula will form a non-zero
angle with the plane of Schlemm's canal.
[0055] FIG. 3B is a stylized perspective view depicting the surface
92 that defines anterior chamber AC of the eye shown in FIG. 3A. In
FIG. 3B, surface 92 is shown having a generally hemispherical
shape. FIG. 3B may be used to illustrate some fundamental geometric
concepts that will be used below to describe the various ocular
implant structures. Geometry is a branch of mathematics concerned
with the properties of space and the shape, size, and relative
position of objects within that space. In geometry, a sphere is a
round object in three-dimensional space. All points on the surface
of a sphere are located the same distance r from a center point so
that the sphere is completely symmetrical about the center point.
In geometry, a point represents an exact location. A point is a
zero-dimensional entity (i.e., it has no length, area, or volume).
Geometrically speaking, at any point on a spherical surface, one
can find a normal direction which is at right angles to the
surface. For a spherical surface all normal directions intersect
the center point of the sphere. Each normal direction will also be
perpendicular to a line that is tangent to the spherical surface.
In FIG. 3B, a normal line N is illustrated using dashed lines.
Normal line N is at right angles to spherical surface 92. Normal
line N is also perpendicular to a reference line TAN. Reference
line TAN is tangent to spherical surface 92 in FIG. 3B.
[0056] As shown in the previous figure, Schlemm's canal is disposed
inside anterior chamber AC. An exemplary method in accordance with
this detailed description may include the step of advancing a
distal portion of a cannula into the anterior chamber of the eye.
The cannula may then be used to access Schlemm's canal, for
example, by piercing the wall of Schlemm's canal with the distal
end of the cannula. An ocular implant may be advanced out of the
distal opening of the cannula and into Schlemm's canal. An
exemplary path 94 taken by an ocular implant as it follows
Schlemm's canal along surface 92 is illustrated using a row of dots
in FIG. 3B.
[0057] As the ocular implant advances into Schlemm's canal, the
ocular implant may press against the outer major wall of Schlemm's
canal and the dome-shaped wall that defines the anterior chamber of
the eye. As the body of the ocular implant presses against the
dome-shaped wall of the eye, the dome-shaped wall provides support
for Schlemm's canal and the ocular implant. The support provided by
the dome-shaped wall may be represented by force vectors. The
direction of these force vectors may be at right angles to points
on the spherical surface that defines the anterior chamber. The
dome shaped wall comprises scleral tissue that is firmer than the
tissue of Schlemm's canal wall. Accordingly, the outer major wall
of Schlemm's canal may be supported by the dome shaped wall as the
ocular implant advances into Schlemm's canal.
[0058] During delivery, it is desirable that the ocular implant
follow the lumen of Schlemm's canal as it is advanced out the
distal opening of the cannula. The ability of the ocular implant to
be advanced into and follow the lumen of Schlemm's canal may be
referred to as trackability. Characteristics of an ocular implant
that affect trackability include axial pushability, lateral
flexibility, and overall shape with respect to the shape of
Schlemm's canal (e.g., radius of curvature and cross-section
profile). Axial pushability generally concerns the ability of an
ocular implant to transmit to the distal end of the ocular implant
an axial force applied to the proximal end of the ocular implant.
Lateral flexibility concerns the ease with which the ocular implant
body can bend to conform to the shape of the lumen. Trackability
may be adversely effected when twisting forces are applied to a
curved body. For example, twisting the body of a curved ocular
implant about its longitudinal axis may cause the curved body to
steer away from a desired path.
[0059] FIG. 4 is a stylized perspective view further illustrating
Schlemm's canal SC and iris 30 shown in FIG. 3A. Schlemm's canal SC
and iris 30 are disposed inside the anterior chamber AC of the eye.
The surface 92 that defines the anterior chamber AC of eye 20 is
depicted using dashed lines in FIG. 4. In the exemplary embodiment
of FIG. 4, Schlemm's canal SC and iris 30 are shown in
cross-section, with a cutting plane passing through the center of a
pupil 32 defined by iris 30. Schlemm's canal SC comprises a first
major side 50, a second major side 52, a first minor side 54, and a
second minor side 56. Schlemm's canal SC forms a ring around iris
30 with pupil 32 disposed in the center of that ring. With
reference to FIG. 4, it will be appreciated that first major side
50 is on the outside of the ring formed by Schlemm's canal SC and
second major side 52 is on the inside of the ring formed by
Schlemm's canal SC. Accordingly, first major side 50 may be
referred to as an outer major side of Schlemm's canal SC and second
major side 52 may be referred to as an inner major side of
Schlemm's canal SC. With reference to FIG. 4, it will be
appreciated that first major side 50 is further from pupil 32 than
second major side 52.
[0060] FIG. 22 is an enlarged cross-sectional view further
illustrating Schlemm's canal SC. Schlemm's canal SC includes a wall
W defining a lumen 58. The shape of Schlemm's canal SC is somewhat
irregular, and can vary from patient to patient. The shape of
Schlemm's canal SC may be conceptualized as a cylindrical-tube that
has been partially flattened. The cross-sectional shape of lumen 58
may be compared to the shape of an ellipse. A major axis 60 and a
minor axis 62 of lumen 58 are illustrated with dashed lines in FIG.
22.
[0061] The length of major axis 60 and minor axis 62 can vary from
patient to patient. The length of minor axis 62 is between one and
thirty micrometers in most patients. The length of major axis 60 is
between one hundred and fifty micrometers and three hundred and
fifty micrometers in most patients.
[0062] With reference to FIG. 22, Schlemm's canal SC has a first
major side 50, a second major side 52, a first minor side 54, and a
second minor side 56. In the exemplary embodiment of FIG. 22, first
major side 50 is longer than both first minor side 54 and second
minor side 56. Also in the exemplary embodiment of FIG. 22, second
major side 52 is longer than both first minor side 54 and second
minor side 56.
[0063] An exemplary path 94 taken by an ocular implant as it
follows Schlemm's canal along surface 92 is illustrated using a row
of dots in FIG. 4. As the ocular implant advances into Schlemm's
canal, the ocular implant may press against the outer major wall of
Schlemm's canal and the dome-shaped wall that defines the anterior
chamber. More particularly, one or more surfaces (e.g., on the
struts) of the ocular implant may press against surface 92, i.e.,
scleral tissue forming part of the dome-shaped wall of the eye, as
the implant moves into and along Schlemm's canal. The scleral
tissue provides support for Schlemm's canal and the ocular implant
as it is advanced into and along Schlemm's canal. The support
provided by the scleral tissue may be represented by one or more
force vectors with each force vector being at right angles to a
point on the spherical surface that defines the anterior chamber of
the eye; these force vectors act on the implant to balance the
forces generated by the implant as the implant is inserted into and
advanced along Schlemm's canal.
[0064] The interaction between the implant's structure and the
tissue forming Schlemm's canal can affect how the implant behaves
as it is inserted into and advanced along Schlemm's canal. For
example, the implant may have surfaces (hereinafter, "landing
surfaces") that engage scleral tissue within Schlemm's canal as the
implant is inserted into and advanced along Schlemm's canal. If the
force vector on a landing surface on one side of the implant
exceeds the force vector on an opposite side of the implant, the
implant may bend or twist as it is advanced. In addition, if the
implant has a preset curve, any bending or twisting of the implant
may direct the curve away from, instead of along, the curve of
Schlemm's canal. Also, the implant may have a preferential bending
plane that will affect the orientation of the implant within a
curved insertion cannula and with the curve of Schlemm's canal as
well as the implant's response to force vectors on its landing
surfaces.
[0065] For example, an ocular implant in accordance with the
present detailed description may include a plurality of spines and
a plurality of landing surfaces that seat against the inner surface
of the dome shaped wall that encloses the anterior chamber so that
the dome shaped wall provides supporting normal forces to the
landing surfaces. The ocular implant may be configured such that a
net twisting moment applied to each spine by the normal forces
supporting the landing surfaces during implantation is reduced or
is substantially zero. The ocular implant may also be configured
such that the normal forces supporting the landing surfaces
primarily or exclusively act to guide each spine along the
preferential bending plane thereof
[0066] FIG. 5A is a photographic image showing a histology slide
HS. Histology slide HS of FIG. 5 was created by sectioning and
staining tissue sampled from a cadaveric eye. An ocular implant 500
was implanted in Schlemm's canal SC of the cadaveric eye prior to
sectioning. The photograph of FIG. 5A was created while examining
the section of tissue using a light microscope. FIG. 5B is a
drawing of the ocular implant 500 used in FIG. 5A. Similar to the
ocular implants described in, e.g., U.S. Pat. No. 7,740,604, US
Publ. No. 2009/0082860, U.S. Pat. No. 8,372,026 and US Publ. No.
2011/0009958, implant 500 in FIG. 5B has spines 504 alternating
with frames 506. The spines and frames have curved cross-sections,
and the circumferential extent of the spine cross-section is less
than the circumferential extent of the frame cross-section. Implant
500 extends along a curved longitudinal axis, and its curvature
plane bisects spines 504. Each frame 506 has two struts 508
extending equally from the curvature plane and, therefore, equally
from the spines on either side of that frame. Optional openings 510
are formed in each frame. Openings 510 communicate with a channel
532 extending along implant 500. Channel 532 has an opening 534
along one side and extending through the spines and frames. An
inlet portion 528 of implant 500 is configured to be disposed in
the anterior chamber of the eye when rest of the implant is
disposed in Schlemm's canal.
[0067] FIG. 6A is a stylized line drawing illustrating histology
slide HS shown in the previous figure. FIG. 6B is a simplified
cross-sectional view illustrating the eye from which the histology
sample was taken. FIG. 6A and FIG. 6B are presented on a single
page to illustrate the location of the histology sample relative to
other portions of the eye 20. As discussed earlier, eye 20 includes
a dome-shaped wall 90 having a surface 92 defining an anterior
chamber AC. Dome-shaped wall 90 of eye 20 comprises a cornea 36 and
scleral tissue 34. The scleral tissue 34 meets the cornea 36 at a
limbus of eye 20. In FIG. 6B, surface 92 is shown having a
generally hemispherical shape. In FIG. 6A, ocular implant 500 is
shown residing in Schlemm's canal SC.
[0068] In some embodiments, as shown in FIG. 2, the implant is
inserted from the anterior chamber through the trabecular meshwork
into Schlemm's canal. Suitable delivery systems for this ab interno
implantation procedure are described in US Publ. No. 2009/0132040,
U.S. Pat. No. 8,337,509, US Publ. No. 2011/0098809, and U.S.
application Ser. No. 13/330,592 (filed Dec. 19, 2011). As the
implant passes through the relatively soft tissue of the trabecular
meshwork, landing surfaces of the implant will engage the
relatively stiffer scleral tissue bounding Schlemm's canal. The
relative position of the landing surfaces with respect to other
structure of the implant (and with respect to the structure of
Schlemm's canal) will govern how reaction forces on the landing
surfaces from this engagement will affect the implant as it is
advanced into Schlemm's canal.
[0069] FIG. 7A is a stylized line drawing showing a cross section
of an ocular implant 500 residing in a section of an eye 20
including Schlemm's canal SC. FIG. 7B is a section view showing
same cross-sectional portion of ocular implant 500 prior to
insertion into Schlemm's canal of eye 20. Implant 500 may be, e.g.,
one of the implants described in U.S. Pat. No. 7,740,604; U.S. Pat.
No. 8,372,026; US 2009/0082860; or US 2011/0009958. In the view
shown in FIG. 7B, no external forces are acting on ocular implant
500 so that it is free to assume an undeformed curved shape free of
stress and/or strain. FIG. 7C is a perspective view showing the
ocular implant 500 being inserted into Schlemm's canal through a
cannula 72. FIG. 7A, FIG. 7B and FIG. 7C may be collectively
referred to as FIG. 7.
[0070] Placing FIG. 7A adjacent to FIG. 7B allows comparisons to be
drawn therebetween. By comparing FIG. 7A to FIG. 7B, it will be
appreciated that ocular implant 500 is assuming substantially the
same orientation in both figures. It is believed that the tissues
of the trabecular meshwork are quite soft and compliant, and they
do not have sufficient stiffness to hold ocular implant 500 in a
twisted orientation different from the orientation that the ocular
implant takes when no external forces are acting on it. A twisted
implant might therefore not remain in the desired position within
Schlemm's canal.
[0071] Ocular implant 500 of FIG. 7B includes a spine 504 and a
frame 506. In the exemplary embodiment of FIG. 7B, frame 506
comprises a first strut 508C and a second strut 508D. As shown,
struts 508C and 508D both extend circumferentially beyond the
circumferential extent of spine 504. First strut 508C and second
strut 508D comprise a first landing surface 542C and a second
landing surface 542D, respectively.
[0072] As shown in FIG. 7C, the implant will engage Schlemm's canal
tissue as it is inserted into and advanced along Schlemm's canal.
The force vectors from engagement of the implant with scleral
tissue partially bordering Schlemm's canal depend on the relative
orientation of landing surfaces and scleral tissue with respect to
the direction of insertion, which in turn depends on the
orientation of the implant within the cannula and the relative
positions of the landing surfaces on the implant. As shown in FIG.
7C, during insertion of implant 500 into Schlemm's canal, landing
surface 542C is engaging the scleral tissue ST bordering Schlemm's
canal more directly than its corresponding landing surface 542D.
This mismatch in engagement may result in a the generation of
different reaction forces on landing surfaces 542C and 542D and may
apply bending or twisting moments to the implant that will twist
implant 500 to move landing surface 542D toward (and perhaps
against) scleral tissue ST. The invention described below reduces
this bending or twisting moment.
[0073] With reference to FIG. 7, it will be appreciated that first
landing surface 542C of first strut 508C and second landing surface
542D of second strut 508D define a footprint line 538. Footprint
line 538 contacts ocular implant 500 at a first point 540C and a
second point 540D. First point 540C is disposed on first landing
surface 542C of first strut 508C. Second point 540D is disposed on
second landing surface 542D of second strut 508D.
[0074] A plane 524 is shown intersecting ocular implant 500 in FIG.
7B. In the embodiment of FIG. 7B, the longitudinal axis of ocular
implant 500 follows a curved path so that the longitudinal axis
defines a plane of curvature POC that bisects spines 504 and frames
506 and is co-planar with plane 524 shown in FIG. 7B. A roll angle
RA of frame 506 is illustrated using angular dimension lines in
FIG. 7B. Roll angle RA extends between plane 524 and footprint line
538. In the embodiment of FIG. 7B, because corresponding struts
508C and 508D extend equal distances from the plane of curvature,
roll angle RA has a magnitude of about ninety degrees. Also in the
embodiment of FIG. 7B, footprint line 538 is generally orthogonal
to the plane of curvature POC of ocular implant 500.
[0075] As an ocular implant advances into Schlemm's canal during a
delivery procedure, the ocular implant may press against the
dome-shaped wall that defines the anterior chamber. More
particularly, one or more struts of the ocular implant may press
against scleral tissue forming part of the dome-shaped wall of the
eye. Landing surfaces of the ocular implant may be seated against
the outer wall of Schlemm's canal and the scleral tissue as it is
advanced into Schlemm's canal. The scleral tissue may provide
support for the outer wall of Schlemm's canal as the ocular implant
is advanced therein. These supporting reaction forces will act
against the ocular implant as the implant engages the wall of
Schlemm's canal.
[0076] For example, as discussed above with respect to FIGS. 7A and
7C, as the ocular implant moves out of delivery cannula 72 into
Schlemm's canal, first landing surface 542C of first strut 508C
engages scleral tissue ST. Because of the slope of the inside back
wall of Schlemm's canal, and the equal heights of the implant
struts within the implant's plane of curvature, the impact force
vector normal to the insertion path of the first landing surface
542C against scleral tissue is greater than the impact force vector
normal to the insertion path of the second landing surface 542D
against scleral tissue. The reaction forces from the scleral tissue
against implant 500 may therefore cause a twisting or bending of
implant 500 as it is advanced into Schlemm's canal that move
landing surface 542 D toward, and perhaps against, scleral tissue
ST.
[0077] Changing the angle of the insertion cannula with respect to
the plane of Schlemm's canal would change the way the implant's
landing surfaces interact with scleral tissue during insertion and,
therefore, any bending or twisting moments applied to the implant.
Visualization requirements and anterior chamber access limitations
may require the cannula to form an angle greater than zero with the
plane of Schlemm's canal. It therefore may be desirable to change
the position of the implant landing surfaces in an effort to reduce
the difference in the magnitude of the reaction forces on landing
surfaces on opposite sides of the implant, such as by changing the
relative heights of the struts with respect to the implant's plane
of curvature.
[0078] FIG. 8A is a stylized line drawing showing an ocular implant
100 residing in a section of an eye 20 including Schlemm's canal
SC. FIG. 8B is a section view showing a portion of ocular implant
100 prior to insertion into Schlemm's canal of eye 20. FIG. 8C is a
perspective view showing the ocular implant 100 being inserted into
Schlemm's canal through a cannula 72. In the view shown in FIG. 8B,
no external forces are acting on ocular implant 100 so that it is
free to assume an undeformed shape free of stress and/or strain. By
comparing FIG. 8A to FIG. 8B, it will be appreciated that ocular
implant 100 is assuming substantially the same orientation in both
figures. As mentioned above, the tissues of the trabecular meshwork
are quite soft and compliant, and they and do not have sufficient
stiffness to hold ocular implant 100 in a twisted orientation
different from the orientation that the ocular implant takes when
no external forces are acting on it.
[0079] Ocular implant 100 of FIG. 8B includes a spine 104 and a
frame 106. In the exemplary embodiment of FIG. 8B, frame 106
comprises a first strut 108C and a second strut 108D. As shown,
struts 108C and 108D both extend circumferentially beyond the
circumferential extent of spine 104. First strut 108C and second
strut 108D comprise a first landing surface 142C and a second
landing surface 142D, respectively. With reference to FIG. 8, it
will be appreciated that first landing surface 142C of first strut
108C and second landing surface 142D of second strut 108D define a
footprint line 138. Footprint line 138 contacts ocular implant 100
at a first point 140C and a second point 140D. First point 140C is
disposed on first landing surface 142C of first strut 108C. Second
point 140D is disposed on second landing surface 142D of second
strut 108D.
[0080] A plane 124 is shown intersecting ocular implant 100 in FIG.
8B. In the embodiment of FIG. 8B, the longitudinal axis of ocular
implant 100 follows a curved path so that the longitudinal axis
defines a plane of curvature POC that is co-planar with plane 124
shown in FIG. 8B. As shown in FIG. 8B, the plane of curvature POC
bisects spine 104 so that the cross-sectional circumferential
extent of spine 104 on one side of the plane of curvature is
substantially equal to the cross-sectional circumferential extent
of spine 104 on the other side of the plane of curvature.
[0081] During implantation, the implant 100 will be oriented with
the curved insertion cannula 72, as suggested by FIG. 8C, such that
the implant's plane of curvature is coplanar with the cannula's
plane of curvature. Thus, adjusting the height of the struts with
respect to the implant's plane of curvature and curved longitudinal
axis will affect the way that the implant's landing surfaces engage
scleral tissue as the implant is advanced into and along Schlemm's
canal.
[0082] A roll angle RB of frame 106 is illustrated using angular
dimension lines in FIG. 8B. Roll angle RB extends between plane 124
and footprint line 138. By comparing FIG. 8B with FIG. 7B described
above, it will be appreciated that because strut 108D extends
further out of the plane of curvature than its opposing strut 108C,
the roll angle RB shown in FIG. 8B has a magnitude different from
the magnitude of roll angle RA shown in FIG. 7B. In the embodiment
of FIG. 8B, angle RB has a magnitude other than ninety degrees.
Also in the embodiment of FIG. 8B, footprint line 138 is generally
skewed relative to the plane of curvature POC of ocular implant
100.
[0083] Differences in the responses of implant 100 and implant 500
can be seen by comparing FIG. 8 to FIG. 7. As shown in FIGS. 8A and
8C, as the ocular implant 100 moves out of delivery cannula 72 into
Schlemm's canal, landing surfaces 142C and 142D engage scleral
tissue ST. Because of the slope of the inside back wall of
Schlemm's canal and the unequal heights of the implant struts with
respect to the implant's plane of curvature, the impact force
vector normal to the insertion path of the first landing surface
142C against scleral tissue is closer to (and possibly equal to)
the impact force vector normal to the insertion path of the second
landing surface 142D against scleral tissue. The decrease in the
difference between the reaction forces on opposite sides of the
implant will decrease any bending or twisting moments applied to
implant 100 during insertion and advancement within Schlemm's
canal.
[0084] FIG. 9 is a perspective view showing ocular implant 500 of
FIG. 7. With reference to FIG. 9, it will be appreciated that
ocular implant 500 defines a cylindrical surface CYL enclosing a
three dimensional volume having a shape similar to a cylinder.
Ocular implant 500 of FIG. 9 includes a spine 504 and a frame 506.
In the exemplary embodiment of FIG. 9, frame 506 comprises a first
strut 508C and a second strut 508D. First strut 508C and second
strut 508D comprise a first landing surface 542C and a second
landing surface 542D, respectively. With reference to FIG. 7, it
will be appreciated that first landing surface 542C of first strut
508C and second landing surface 542D of second strut 508D define a
footprint line 538. Footprint line 538 contacts ocular implant 500
at a first point 540C and a second point 540D. First point 540C is
disposed on first landing surface 542C of first strut 508C. Second
point 540D is disposed on second landing surface 542D of second
strut 508D. With reference to FIG. 9, it will be appreciated that
footprint line 538 lies on the cylindrical surface CYL defined by
ocular implant 500.
[0085] FIG. 10 is an additional perspective view showing ocular
implant 100 of FIG. 8. With reference to FIG. 10, it will be
appreciated that ocular implant 100 defines a conical surface C
enclosing a three dimensional volume having a shape similar to a
cone. Ocular implant 100 of FIG. 10 includes a spine 104 and a
frame 106. In the exemplary embodiment of FIG. 10, frame 106
comprises a first strut 108C and a second strut 108D. First strut
108C and second strut 108D comprise a first landing surface 142C
and a second landing surface 142D, respectively. With reference to
FIG. 7, it will be appreciated that first landing surface 142C of
first strut 108C and second landing surface 142D of second strut
108D define a footprint line 138. Footprint line 138 contacts
ocular implant 100 at a first point 140C and a second point 140D.
First point 140C is disposed on first landing surface 142C of first
strut 108C. Second point 140D is disposed on second landing surface
142D of second strut 108D. With reference to FIG. 10, it will be
appreciated that footprint line 138 lies on the conical surface C
defined by ocular implant 100.
[0086] FIG. 11A is a stylized perspective view showing a conical
surface C that is sized and positioned so as to intersect a
hemispherical surface S in two places. A first line L1 is formed
where the two surfaces intersect a first time. A second line L2 is
formed where conical surface C and hemispherical surface S
intersect a second time. A first point 142A is positioned on first
line L1 and a second point 142B is disposed on second line L2.
[0087] FIG. 11B is a stylized perspective view showing the ocular
implant 100 of FIG. 8 disposed inside a chamber V defined by a
hemispherical surface S. Ocular implant 100 contacts hemispherical
surface S at a first point 140A, a second point 140B, a third point
140C, a fourth point 140D, a fifth point 140E, and a sixth point
140F. First point 140A is disposed on a first landing surface 142A
of ocular implant 100. Second point 140B is disposed on a second
landing surface 142B of ocular implant 100. Third point 140C and
fourth point 140D are disposed on a third landing surface 142C and
a fourth landing surface 142D, respectively. Fifth point 140E and
sixth point 140F are disposed on a fifth landing surface 142E and a
sixth landing surface 142F, respectively.
[0088] Applicant has created ocular implants designed to work in
harmony with the dome shaped wall that defines the anterior chamber
of the human eye. In some useful embodiments, the ocular implants
are configured such that reaction forces applied to the ocular
implant by scleral tissue while the ocular implant is being
advanced into Schlemm's canal subject the ocular implant to pure
bending with little or no twisting. The ocular implant may be
configured such that a net twisting moment applied to each spine by
the normal forces supporting the landing surfaces is substantially
zero. The ocular implant may also be configured such that the
normal forces supporting the landing surfaces primarily or
exclusively act to bend each spine along the preferential bending
plane thereof.
[0089] The implant will bend preferentially about the region having
the smallest circumferential extent, i.e., the spine. In the
embodiment shown FIGS. 8, 10 and 11B, because the spines extend
equally on both sides of the plane of curvature POC, the plane of
curvature and the preferential bending plane are coplanar. If the
roll angle of the implant is set so that the normal forces on the
strut landing surfaces are substantially equal (i.e., the angle of
the footprint equals the angle of the back wall of Schlemm's
canal), the net forces on the implant during insertion and
advancement will cause the implant to bend along its preferential
bending plane with no net twisting about the plane. In some other
useful embodiments (discussed below with respect to FIGS. 15-18 and
19B), the preferential bending plane of each spine extends in a
direction that is at right angles to a conical surface defined by
the ocular implant.
[0090] In the embodiment of FIG. 11B, ocular implant 100 defines a
conical surface C. Ocular implant 100 contacts conical surface C at
a first point 140A, a second point 140B, a third point 140C, a
fourth point 140D, a fifth point 140E, and a sixth point 140F. Due
to page size constraints, conical surface C is truncated in FIG.
21. Conical surface C intersects hemispherical surface S in two
places. First point 140A, third point 140C, and fifth point 140E
are disposed on a first line formed where conical surface C and
hemispherical surface S intersect a first time. Second point 140B,
fourth point 140D, and sixth point 140F are disposed on a second
line formed where the two surfaces intersect a second time.
[0091] FIG. 12A, FIG. 12B and FIG. 12C are plan views of the ocular
implant 100 of FIG. 8 created using multiview projection. FIG. 12A,
FIG. 12B and FIG. 12C may be referred to collectively as FIG. 12.
It is customary to refer to multiview projections using terms such
as front view, top view, and side view. In accordance with this
convention, FIG. 12A may be referred to as a top view of ocular
implant 100, FIG. 12B may be referred to as a side view of ocular
implant 100, and FIG. 12C may be referred to as a bottom view of
ocular implant 100. The terms top view, side view, and bottom view
are used herein as a convenient method for differentiating between
the views shown in FIG. 12. It will be appreciated that the implant
shown in FIG. 12 may assume various orientations without deviating
from the spirit and scope of this detailed description.
Accordingly, the terms top view, side view, and bottom view should
not be interpreted to limit the scope of the invention recited in
the attached claims.
[0092] Ocular implant 100 of FIG. 12 comprises a body 102 that
extends along a longitudinal central axis 120. In the exemplary
embodiment of FIG. 12, longitudinal central axis 120 follows a
curved path such that longitudinal central axis 120 defines a
curvature plane 122. In some useful embodiments, the radius of
curvature of the ocular implant is substantially equal to the
radius of curvature of Schlemm's canal. Body 102 of ocular implant
100 has a distal end 126, a proximal inlet portion 128 and an
intermediate portion 130 extending between the proximal inlet
portion 128 and the distal end 126. Intermediate portion 130
comprises a plurality of spines 104 and a plurality of frames 106.
The spines 104 of intermediate portion 130 include a first spine
104A, a second spine 104B and a third spine 104C. The frames 106 of
intermediate portion 130 include a first frame 106A, a second frame
106B and a third frame 106C. Ocular implant 100 is sized and
configured so that the spines and frames are disposed in and
supporting Schlemm's canal and the inlet 128 is disposed in the
anterior chamber to provide for flow of aqueous humor from the
anterior chamber through Schlemm's canal to outflow channels
communicating with Schlemm's canal.
[0093] In FIG. 12, first spine 104A can be seen extending distally
beyond proximal inlet portion 128. First frame 106A comprises a
first strut 108A and a second strut 108B that extend between first
spine 104A and second spine 104B. With reference to FIG. 12, it
will be appreciated that second frame 106B abuts a distal end of
second spine 104B. In the embodiment of FIG. 12, second frame 106B
comprises a first strut 108C and a second strut 108D that extend
between second spine 104B and third spine 104C. Third frame 106C
can be seen extending between third spine 104C and distal end 126
of ocular implant 100 in FIG. 12. Third frame 106C comprises a
first strut 108E and a second strut 108F.
[0094] Body 102 of ocular implant 100 defines a channel 132 that
opens into a channel opening 134. With reference to FIG. 12, it
will be appreciated that channel 132 and channel opening 134
extending together through body 102 across first spine 104A, second
spine 104B, third spine 104C, first frame 106A, second frame 106B,
and third frame 106C. Optional additional openings 110
communicating with channel 132 are disposed between the spines and
are surrounded by the struts.
[0095] With particular reference to FIG. 12B, it will be
appreciated that curvature plane 122 intersects first spine 104A,
second spine 104B, and third spine 104C. In the embodiment of FIG.
12A, curvature plane 122 bisects each spine into two halves. The
two halves of each spine are symmetrically shaped about curvature
plane 122 in the embodiment of FIG. 12A. With reference to FIG. 12B
and FIG. 12C, it will be appreciated that the frames of ocular
implant 100 are not symmetric about curvature plane 122.
[0096] FIG. 13A is a plan view showing ocular implant 100 of FIG.
8. FIG. 13B is an enlarged section view taken along section line
B-B shown in FIG. 13A. FIG. 13C is an additional enlarged section
view taken along section line C-C shown in FIG. 13A. FIG. 13A, FIG.
13B and FIG. 13C may be collectively referred to as FIG. 13.
[0097] Ocular implant 100 of FIG. 13 comprises a body 102 that
extends along a longitudinal central axis 120. Body 102 of ocular
implant 100 has a distal end 126, a proximal inlet portion 128 and
an intermediate portion 130 extending between the proximal inlet
portion 128 and the distal end 126. Intermediate portion 130
comprises a plurality of spines 104 and a plurality of frames 106.
The spines 104 of intermediate portion 130 include a first spine
104A, a second spine 104B and a third spine 104C. The frames 106 of
intermediate portion 130 include a first frame 106A, a second frame
106B and a third frame 106C.
[0098] In FIG. 13, first spine 104A can be seen extending distally
beyond proximal inlet portion 128. First frame 106A comprises a
first strut 108A and a second strut 108B that extend between first
spine 104A and second spine 104B. With reference to FIG. 13, it
will be appreciated that second frame 106B abuts a distal end of
second spine 104B. In the embodiment of FIG. 13, second frame 106B
comprises a first strut 108C and a second strut 108D that extend
between second spine 104B and third spine 104C. Third frame 106C
can be seen extending between third spine 104C and distal end 126
of ocular implant 100 in FIG. 13. Third frame 106C comprises a
first strut 108E and a second strut 108F.
[0099] Body 102 of ocular implant 100 defines a channel 132 that
opens into a channel opening 134. With particular reference to FIG.
13A, it will be appreciated that channel 132 and channel opening
134 extending together through body 102 across first spine 104A,
second spine 104B, third spine 104C, first frame 106A, second frame
106B, and third frame 106C. In this embodiment, the struts on one
side of the implant extend further out of the plane of curvature
that their corresponding struts on the opposite side of the
implant. Thus, as shown in FIG. 13B, strut 108F extends further out
of the plane of curvature (corresponding with longitudinal central
axis 120) than its opposing strut 108E.
[0100] FIG. 14A is a perspective view showing ocular implant 100 of
FIG. 8. Ocular implant 100 comprises a body 102 extending along a
longitudinal central axis 120. A first plane 124A is shown
intersecting ocular implant 100 in FIG. 14A. In the embodiment of
FIG. 14A, longitudinal central axis 120 follows a path that is
generally curved such that longitudinal central axis 120 defines a
plane of curvature that is co-planar with first plane 124A shown in
FIG. 14A. A second plane 124B, a third plane 124C, and a fourth
plane 124D are also shown intersecting ocular implant 100 in FIG.
14A. Second plane 124B, third plane 124C, and fourth plane 124D are
all transverse to ocular implant 100 and longitudinal central axis
120 in the embodiment of FIG. 14A. More particularly, in the
exemplary embodiment of FIG. 14A, second plane 124B is orthogonal
to a reference line 136B that lies in first plane 124A and is
tangent to longitudinal central axis 120. Third plane 124C is
orthogonal to a reference line 136C that lies in first plane 124A
and is tangent to longitudinal central axis 120. Third plane 124D
is orthogonal to a reference line 136D that lies in first plane
124A and is tangent to longitudinal central axis 120.
[0101] Body 102 of ocular implant 100 has a distal end 126, a
proximal inlet portion 128 and an intermediate portion 130
extending between the proximal inlet portion 128 and the distal end
126. Intermediate portion 130 comprises a plurality of spines 104
and a plurality of frames 106. The frames 106 of intermediate
portion 130 include a first frame 106A, a second frame 106B and a
third frame 106C. In FIG. 14A, second plane 124B is shown extending
through first frame 106A. Third plane 124C and fourth plane 124D
are shown extending through second frame 106B and third frame 106C,
respectively, in FIG. 14A.
[0102] The spines 104 of intermediate portion 130 include a first
spine 104A, a second spine 104B and a third spine 104C. In FIG. 14,
first spine 104A can be seen extending distally beyond proximal
inlet portion 128. First frame 106A comprises a first strut 108A
and a second strut 108B that extend between first spine 104A and
second spine 104B. With reference to FIG. 14, it will be
appreciated that second frame 106B abuts a distal end of second
spine 104B. In the embodiment of FIG. 14, second frame 106B
comprises a third strut and a fourth strut that extend between
second spine 104B and third spine 104C. Third frame 106C can be
seen extending between third spine 104C and distal end 126 of
ocular implant 100 in FIG. 14. Third frame 106C comprises a fifth
strut and a sixth strut.
[0103] With reference to FIG. 14A, it will be appreciated that
first plane 124A intersects the spines of ocular implant 100. In
the embodiment of FIG. 14A, first plane 124A bisects each spine
into two halves. The two halves of each spine are symmetrically
shaped about first plane 124A in the embodiment of FIG. 14A.
[0104] In the exemplary embodiment of FIG. 14A, each frame 106
comprises two struts. In some useful embodiments, each strut
includes a landing surface and each frame is configured to support
the spines in a location offset from an outer major side of
Schlemm's canal while the ocular implant is in Schlemm's canal and
the landing surfaces are engaging the outer major side of Schlemm's
canal. In the embodiment of FIG. 14A, first frame 106A, second
frame 106B and third frame 106C are each oriented at a roll
angle.
[0105] First frame 106A of FIG. 14A comprises a first strut 108A
and a second strut 108B. The roll angle of first frame 106A may be
defined by a footprint line defined by a first landing surface of
first strut 108A and a second landing surface of second strut 108B.
In the embodiment of FIG. 14A, the footprint line will lie in
second plane 124B and be skewed relative to first plane 124A. The
angle between the footprint line and first plane 124A may be
referred to as the roll angle of the frame. In the exemplary
embodiment of FIG. 14A, second frame 106B and third frame 106C have
roll angles similar to the roll angle of first frame 106A.
[0106] FIG. 14B is a plan view further illustrating first frame
106A and second plane 124B shown in FIG. 14A. With reference to
FIG. 14B, it will be appreciated that first frame 106A has a
lateral cross-sectional shape F that lies in second plane 124B.
First frame 106A comprises a first strut 108A and a second strut
108B. First plane 124A is shown intersecting first frame 106A in
FIG. 14B.
[0107] A roll angle RA of first frame 106A is illustrated using
angular dimension lines in FIG. 14B. Roll angle RA extends between
first plane 124A and a first footprint line 138A. In the exemplary
embodiment of FIG. 14, first footprint line 138A is defined by a
first point 140A and a second point 140B. First point 140A is
disposed on a first landing surface 142A of first strut 108A.
Second point 140B is disposed on a second landing surface 142B of
second strut 108B. As discussed above, in this embodiment the
struts on one side of the implant extend further out of the plane
of curvature than their corresponding struts on the opposite side
of the implant. Thus, as shown in FIG. 14B, strut 108B extends
further out of the plane of curvature 124A than its opposing strut
108A.
[0108] FIG. 15A, FIG. 15B and FIG. 15C are multi-plan views of yet
another exemplary ocular implant 300 in accordance with the present
detailed description. FIG. 15A, FIG. 15B and FIG. 15C may be
referred to collectively as FIG. 15. It is customary to refer to
multi-view projections using terms such as front view, top view,
and side view. In accordance with this convention, FIG. 15A may be
referred to as a top view of ocular implant 300, FIG. 15B may be
referred to as a side view of ocular implant 300, and FIG. 15C may
be referred to as a bottom view of ocular implant 300. The terms
top view, side view, and bottom view are used herein as a
convenient method for differentiating between the views shown in
FIG. 15. It will be appreciated that the implant shown in FIG. 15
may assume various orientations without deviating from the spirit
and scope of this detailed description. Accordingly, the terms top
view, side view, and bottom view should not be interpreted to limit
the scope of the invention recited in the attached claims.
[0109] Ocular implant 300 of FIG. 15 comprises a body 302 that
extends along a longitudinal central axis 320. In the exemplary
embodiment of FIG. 15, longitudinal central axis 320 follows a
curved path such that longitudinal central axis 320 defines a
curvature plane 322. Body 302 of ocular implant 300 has a distal
end 326, a proximal inlet portion 328 and an intermediate portion
330 extending between the proximal inlet portion 328 and the distal
end 326. Intermediate portion 330 comprises a plurality of spines
304 and a plurality of frames 306. The spines 304 of intermediate
portion 330 include a proximal-most spine 304A, an intermediate
spine 304B and a distal-most spine 304C. The frames 306 of
intermediate portion 330 include a proximal-most frame 306A, an
intermediate frame 306B and a distal-most frame 306C. Ocular
implant 300 is sized and configured so that the spines and frames
are disposed in and supporting Schlemm's canal and the inlet 328 is
disposed in the anterior chamber to provide for flow of aqueous
humor from the anterior chamber through Schlemm's canal to outflow
channels communicating with Schlemm's canal.
[0110] In FIG. 15, proximal-most spine 304A can be seen extending
distally beyond proximal inlet portion 328. Proximal-most frame
306A comprises a first strut 308A and a second strut 308B that
extend between proximal-most spine 304A and intermediate spine
304B. With reference to FIG. 15, it will be appreciated that
intermediate frame 306B abuts a distal end of intermediate spine
304B. In the embodiment of FIG. 15, intermediate frame 306B
comprises a third strut 308C and a fourth strut 308D that extend
between intermediate spine 304B and distal-most spine 304C.
Distal-most frame 306C can be seen extending between distal-most
spine 304C and distal end 326 of ocular implant 300 in FIG. 15.
Distal-most frame 306C comprises a fifth strut 308E and a sixth
strut 308F.
[0111] Body 302 of ocular implant 300 defines a channel 332 that
opens into a channel opening 334. With reference to FIG. 15, it
will be appreciated that channel 332 and channel opening 334
extending together through body 302 across proximal-most spine
304A, intermediate spine 304B, distal-most spine 304C,
proximal-most frame 306A, intermediate frame 306B, and distal-most
frame 306C. Optional additional openings 310 communicating with
channel 332 are disposed between the spines and are surrounded by
the struts.
[0112] FIG. 16A is a plan view showing ocular implant 300 of FIG.
15. FIG. 16B is an enlarged section view taken along section line
B-B shown in FIG. 16A. FIG. 16C is an additional enlarged section
view taken along section line C-C shown in FIG. 16A. FIG. 16A, FIG.
16B and FIG. 16C may be collectively referred to as FIG. 16.
[0113] Ocular implant 300 of FIG. 16 comprises a body 302 that
extends along a longitudinal central axis 320 which, in this view,
lies in the plane of curvature of implant 300. Body 302 of ocular
implant 300 has a distal end 326, a proximal inlet portion 328 and
an intermediate portion 330 extending between the proximal inlet
portion 328 and the distal end 326. Intermediate portion 330
comprises a plurality of spines 304 and a plurality of frames 306.
The spines 304 of intermediate portion 330 include a proximal-most
spine 304A, an intermediate spine 304B and a distal-most spine
304C. The frames 306 of intermediate portion 330 include a
proximal-most frame 306A, an intermediate frame 306B and a
distal-most frame 306C. As shown, unlike the embodiment of FIG. 8,
in this embodiment the plane of curvature does not bisect the
spines.
[0114] In FIG. 16, proximal-most spine 304A can be seen extending
distally beyond proximal inlet portion 328. Proximal-most frame
306A comprises a first strut 308A and a second strut 308B that
extend between proximal-most spine 304A and intermediate spine
304B. With reference to FIG. 16, it will be appreciated that
intermediate frame 306B abuts a distal end of intermediate spine
304B. In the embodiment of FIG. 16, intermediate frame 306B
comprises a third strut 308C and a fourth strut 308D that extend
between intermediate spine 304B and distal-most spine 304C.
Distal-most frame 306C can be seen extending between distal-most
spine 304C and distal end 326 of ocular implant 300 in FIG. 16.
Distal-most frame 306C comprises a fifth strut 308E and a sixth
strut 308F.
[0115] Body 302 of ocular implant 300 defines a channel 332 that
opens into a channel opening 334. With reference to FIG. 16, it
will be appreciated that channel 332 and channel opening 334
extending together through body 302 across proximal-most spine
304A, intermediate spine 304B, distal-most spine 304C,
proximal-most frame 306A, intermediate frame 306B, and distal-most
frame 306C. In this embodiment, the struts on one side of the
implant extend further out of the plane of curvature (shown as a
dotted line in FIG. 16B) than their corresponding struts on the
opposite side of the implant. Thus, as shown in FIG. 16B, strut
308F extends further out of the plane of curvature than its
opposing strut 308E. It can also be seen from FIG. 16B that spine
304C extends further out of the plane of curvature on one side than
on the other and that the struts 308E and 308F both extend
circumferentially equally beyond the circumferential extend of
spine 304C. Thus, implant 300 does not bend preferentially in the
implant's plane of curvature.
[0116] FIG. 17A is a perspective view showing ocular implant 300 of
FIGS. 15 and 16. A first plane 324A is shown intersecting ocular
implant 300 in FIG. 17A. Ocular implant 300 of FIG. 17A comprises a
body 302 extending along a longitudinal central axis 320. In the
embodiment of FIG. 17A, longitudinal central axis 320 follows a
path that is generally curved such that longitudinal central axis
320 defines a plane of curvature POC.
[0117] In the embodiment of FIG. 17A, plane of curvature POC is
co-planar with first plane 324A shown in FIG. 17A. With reference
to FIG. 17A, it will be appreciated that plane of curvature POC
would no longer be coplanar with first plane 324A if ocular implant
300 was rotated. In some methods in accordance with this detailed
description, ocular implant may be advanced into Schlemm's canal
while the plane of curvature of the ocular implant is co-planar
with a plane of curvature of Schlemm's canal.
[0118] A second plane 324B and a third plane 324C are shown
extending transversely across body 302 of ocular implant 300 in
FIG. 17A. With reference to FIG. 17A, it will be appreciated that
third plane 324C extends through a distal-most spine 304C of ocular
implant 300. Second plane 324B is shown extending through a
distal-most frame 306C of ocular implant 300 in FIG. 17A. In the
exemplary embodiment of FIG. 17A, second plane 324B is orthogonal
to a reference line 336B. Reference line 336B is tangent to
longitudinal central axis 320 and is shown lying on first plane
324A in FIG. 17A.
[0119] Body 302 of ocular implant 300 has a distal end 326, a
proximal inlet portion 328 and an intermediate portion 330
extending between the proximal inlet portion 328 and the distal end
326. Intermediate portion 330 comprises a plurality of spines 304
and a plurality of frames 306. The frames 306 of intermediate
portion 330 include a proximal-most frame 306A, an intermediate
frame 306B and a distal-most frame 306C. Second plane 324B is shown
extending through distal-most frame 306C in FIG. 17A. In the
exemplary embodiment of FIG. 17A, body 302 includes a single
intermediate frame 306B. It will be appreciated, however, that body
302 include any number of intermediate frames without deviating
from the spirit and scope of the present detailed description.
[0120] The spines 304 of intermediate portion 330 include a
proximal-most spine 304A, an intermediate spine 304B and a
distal-most spine 304C. In FIG. 17A, third plane 324C is shown
extending through distal-most spine 304C. In the exemplary
embodiment of FIG. 17A, body 302 includes a single intermediate
spine 304B. It will be appreciated, however, that body 302 include
any number of intermediate spines without deviating from the spirit
and scope of the present detailed description.
[0121] In FIG. 17A, proximal-most spine 304A can be seen extending
distally beyond proximal inlet portion 328. Proximal-most frame
306A comprises a first strut 308A and a second strut 308B that
extend between proximal-most spine 304A and intermediate spine
304B. With reference to FIG. 17, it will be appreciated that
intermediate frame 306B abuts a distal end of intermediate spine
304B. In the embodiment of FIG. 17, intermediate frame 306B
comprises a first strut and a second strut that extend between
intermediate spine 304B and distal-most spine 304C. Distal-most
frame 306C can be seen extending between distal-most spine 304C and
distal end 326 of ocular implant 300 in FIG. 17. Distal-most frame
306C comprises a first strut 308E and a second strut 308F. Second
plane 324B is shown extending through distal-most frame 306C in
FIG. 17A.
[0122] FIG. 17B is an enlarged plan view of second plane 324B shown
in FIG. 17A. With reference to FIG. 17A, it will be appreciated
that second plane 324B intersects a first strut 308E and a second
strut 308F of distal-most frame 306C. In FIG. 17B, a profile PE of
first strut 308E is shown lying on second plane 324B. A profile PF
of second strut 308F is also shown lying on second plane 324B in
FIG. 17B. The profile of each strut is filled with a cross-hatch
pattern in FIG. 17B.
[0123] In the embodiment of FIG. 17, the body of ocular implant 300
extends along a longitudinal central axis that is generally curved
such that the longitudinal central axis defines a plane of
curvature POC that is represented by a dashed line in FIG. 17B. A
roll angle RA of distal-most frame 306C is illustrated using
angular dimension lines in FIG. 17B. Roll angle RA extends between
plane of curvature POC and a first footprint line 338C. In the
exemplary embodiment of FIG. 17, first footprint line 338C is
defined by a first point 340E and a second point 340F. First point
340E is disposed on a first landing surface 342E of first strut
308E. Second point 340F is disposed on a second landing surface
342F of second strut 308F.
[0124] Upon advancement of ocular implant 300 into Schlemm's canal,
and depending on the angle of the delivery cannula with respect to
the plane of Schlemm's canal during insertion, first landing
surface 342E of first strut 308E and second landing surface 342F of
second strut 308F may seat against the inner surface of the dome
shaped wall that encloses the anterior chamber with the dome shaped
wall providing normal forces supporting the landing surfaces. In
some useful embodiments, roll angle RA is selected such that, when
ocular implant 300 is advanced into Schlemm's canal landing
surfaces of first strut 308E and second strut 308F are seated
against the dome-shaped wall that defines the anterior chamber of
the eye with substantially equal force. The decrease in the
difference between the reaction forces on opposite sides of the
implant will decrease any bending or twisting moments applied to
implant 300 during insertion and advancement within Schlemm's
canal.
[0125] FIG. 17C is an enlarged plan view of third plane 324C shown
in FIG. 17A. As shown in FIG. 17A, third plane 324C intersects
distal-most spine 304C. Accordingly, distal-most spine 304C is
shown in cross-section in FIG. 17C. Distal-most spine 304C has a
profile LC that is shown lying on third plane 324C in FIG. 17C.
[0126] In the embodiment of FIG. 17, the body of ocular implant 300
extends along a longitudinal central axis that is generally curved
such that the longitudinal central axis defines a plane of
curvature POC that is represented by a dashed line in FIG. 17C.
Because the plane of curvature POC does not bisect spine 304C,
spine 304C will not bend preferentially about POC.
[0127] Upon advancement of ocular implant 300 into Schlemm's canal,
the landing surfaces may seat against the inner surface of the dome
shaped wall that encloses the anterior chamber with the dome shaped
wall providing normal forces supporting the landing surfaces. Each
spine of ocular implant 300 may be configured to preferentially
bend along a preferential bending plane. In some useful
embodiments, each spine is rotationally offset relative to a first
adjacent frame and a second adjacent frame by an angle selected
such that the normal forces supporting the landing surfaces
primarily or exclusively act to bend each spine along the
preferential bending plane thereof. In some useful embodiments,
each spine is rotationally offset relative to a first adjacent
frame and a second adjacent frame by an angle selected such that a
net twisting moment applied to each spine by the normal forces is
substantially zero. The arrangement described above may minimize
any twisting of the ocular implant body as the ocular implant is
advanced into Schlemm's canal as part of a delivery procedure. This
arrangement may also provide better trackability than devices that
do not include these design features.
[0128] As shown in FIG. 17C, distal-most spine 304C of ocular
implant 300 has a first lateral extent EF and a second lateral
extent ES. In some useful embodiments, an aspect ratio of first
lateral extent EF to second lateral extent ES is greater than about
one. In some useful embodiments, the aspect ratio of first lateral
extent EF to second lateral extent ES is greater than about three.
The relationships described above may advantageously cause
distal-most spine 304C to preferential bend more along one
direction over another by, e.g., bending about the thinnest portion
of the device.
[0129] With reference to FIG. 17C, it will be appreciated that
distal-most spine 304C has a thickness T. In some useful
embodiments, an aspect ratio of first lateral extent EF to
thickness T may be selected such that distal-most spine 304C
preferentially bends more along one direction over another. In some
useful embodiments, an aspect ratio of first lateral extent EF to
thickness T is greater than about one. In some useful embodiments,
the aspect ratio of first lateral extent EF to thickness T is
greater than about three.
[0130] FIG. 18A is an additional perspective view of ocular implant
300 shown in the previous figure. Ocular implant 300 of FIG. 18A
includes a distal-most spine 304C and a distal-most frame 306C. In
the exemplary embodiment of FIG. 18A, distal-most frame 306C
comprises a first strut 308E and a second strut 308F. FIG. 18B is a
stylized isometric view showing the profiles of distal-most spine
304C, first strut 308E and second strut 308F. The profile of
distal-most spine 304C was created where a third plane 324C
intersects ocular implant 300. Similarly, the profiles of first
strut 308E and second strut 308F were created where a second plane
324B intersects ocular implant 300 in FIG. 18A.
[0131] The profiles of first strut 308E and second strut 308F are
labeled PE and PF in FIG. 18B. The profile of distal-most spine
304C is labeled LC in FIG. 18B. With reference to those profiles,
it will be appreciated that first strut 308E and second strut 308F
comprise a first landing surface 342E and a second landing surface
342F, respectively. In FIG. 18B, a first normal force FE is
represented by an arrow that is shown contacting first landing
surface 342A. A second normal force FF is represented by an arrow
that is shown contacting second landing surface 342A in FIG.
18.
[0132] Distal-most spine 304C of FIG. 18, is configured to
preferentially bend in a preferential bending direction D shown in
FIG. 18B. In some useful embodiments, ocular implant 300 is
configured so that direction D extends at right angles to a point
on a spherical surface that defines the anterior chamber when the
landing surfaces of the ocular implant are seated against the
dome-shaped wall that defines the anterior chamber. Also in some
useful embodiments, ocular implant 300 is configured so that
direction D extends at right angles to a point on a conical surface
defined by ocular implant 300. With reference to FIG. 18, it will
be appreciated that direction D is generally parallel to the
directions of first normal force vector FE and second normal force
vector FF.
[0133] In the embodiment of FIG. 18, first strut 308E, second strut
308F and distal-most spine 304C are configured such that, when
ocular implant 300 is advanced along Schlemm's canal as part of a
delivery procedure the landing surfaces of first strut 308E and
second strut 308F will be seated against the dome-shaped wall
defining the anterior chamber. When first landing surface 342A and
second landing surface 342B contact the outer major wall of
Schlemm's canal, the dome-shaped wall provides normal forces to
support first strut 308E and second strut 308F. In the embodiment
of FIG. 18, ocular implant 300 is configured such that normal
forces applied to the landing surfaces of first strut 308E and
second strut 308F primarily or exclusively act to bend first spine
304C along its preferential bending plane PBP. In some useful
embodiments, each spine is rotationally offset relative to a first
adjacent frame and a second adjacent frame by an angle selected
such that the normal forces supporting the landing surfaces of the
frames primarily or exclusively act to bend each spine along the
preferential bending plane thereof. In some useful embodiments,
each spine is rotationally offset relative to a first adjacent
frame and a second adjacent frame by an angle selected such that a
net twisting moment applied to each spine by the normal forces is
substantially zero.
[0134] FIG. 19A and FIG. 19B are perspective views showing distal
portions ocular implant 100 of FIG. 8 and ocular implant 300 of
FIG. 15, respectively. FIG. 19A and FIG. 19B are presented on a
single page so that second ocular implant 300 can be easily
compared and contrasted to first ocular implant 100. FIG. 19A and
FIG. 19B may be collectively referred to as FIG. 19. In FIG. 19,
the body of each ocular implant extends along a longitudinal
central axis that is generally curved such that the longitudinal
central axis defines a plane of curvature POC. Each plane of
curvature POC is represented by a dashed line in FIG. 19.
[0135] Ocular implant 100 includes a distal-most spine 104C, and
ocular implant 300 includes a distal-most spine 304C. As shown in
FIG. 19A, plane of curvature POC bisects spine 104C. Spine 104C
will bend preferentially about POC. In the embodiment of FIG. 19B,
the plane of curvature POC does not bisect distal-most spine 304C
of ocular implant 300. Spine 304C will not bend preferentially in
plane POC.
[0136] In FIG. 19, two normal forces are shown acting on each
ocular implant. A first normal force FE is represented by an arrow
that is shown contacting a first landing surface of each ocular
implant. A second normal force FF is represented by an arrow that
is shown contacting second landing surface of each ocular implant.
The arrows representing first normal force FE and second normal
force FF are force vectors representing reaction forces provided by
the dome-shaped wall of the eye. The dome-shaped wall of the eye
provides support for the outer major wall of Schlemm's canal and
the ocular implant during delivery. The support provided by the
dome-shaped wall may be represented by the force vectors shown in
FIG. 19. With reference to FIG. 19, it will be appreciated that
direction D is generally parallel to the directions of first normal
force vector FE and second normal force vector FF.
[0137] FIG. 20 is a perspective view showing an exemplary ocular
implant 300 in accordance with this detailed description. Ocular
implant 300 of FIG. 20 comprises a body 302 including a plurality
of spines 304 and a plurality of frames 306. The frames 306 of body
302 include a first frame 306A, a second frame 306B and a third
frame 306C.
[0138] First frame 306A comprises a first strut 308A and a second
strut 308B. First strut 308A and second strut 308B comprise a first
landing surface 342A and a second landing surface 342B,
respectively. First landing surface 342A of first strut 308A and
second landing surface 342B of second strut 308B define a first
footprint line 338A. Second frame 306B comprises a first strut 308C
and a second strut 308D. First strut 308C comprises a first landing
surface 342C and second strut 308D comprises a second landing
surface 342D. First landing surface 342C of first strut 308C and
second landing surface 342D of fourth strut 308D define a second
footprint line 338B. Third frame 306C includes a first strut 308E
and a second strut 308F. First strut 308E and second strut 308F
have a first landing surface 342E and a second landing surface
342F, respectively. First landing surface 342E of first strut 308E
and second landing surface 342F of second strut 308F define a third
footprint line 338C. In FIG. 20, first footprint line 338A, second
footprint line 338B, and third footprint line 338C are shown
intersecting at an apex 344 of a conical surface C.
[0139] Body 302 of ocular implant 300 has a distal end 326, a
proximal inlet portion 328 and an intermediate portion 330
extending between proximal inlet portion 328 and distal end 326.
Intermediate portion 330 of body 302 includes first frame 306A,
second frame 306B, third frame 306C and a plurality of spines 304.
The spines 304 of intermediate portion 330 include a first spine
304A, a second spine 304B and a third spine 304C. In FIG. 20, first
frame 306A can be seen extending between first spine 304A and
second spine 304B. With reference to FIG. 20, it will be
appreciated that second frame 306B extends between second spine
304B and third spine 304C. In the embodiment of FIG. 20, third
frame 306C extends between third spine 304C and distal end 326 of
ocular implant 300 in FIG. 20.
[0140] In the embodiment of FIG. 20, each of first spine 304A,
second spine 304B, and third spine 304C are configured to
preferentially bend in a direction that is at right angles to
conical surface C defined by first footprint line 338A, second
footprint line 338B, and third footprint line 338C.
[0141] FIG. 21 is a stylized perspective view showing Schlemm's
canal SC encircling an iris 30. With reference to FIG. 21, it will
be appreciated that Schlemm's canal SC may overhang iris 30
slightly. Iris 30 defines a pupil 32. Schlemm's canal SC forms a
ring around iris 30 with pupil 32 disposed in the center of that
ring. With reference to FIG. 21, it will be appreciated that
Schlemm's canal SC has a first major side 50, a second major side
52, a first minor side 54, and a second minor side 56. With
reference to FIG. 21, it will be appreciated that first major side
50 is further from pupil 32 than second major side 52. In the
exemplary embodiment of FIG. 21, first major side 50 is an outer
major side of Schlemm's canal SC and second major side 52 is an
inner major side of Schlemm's canal SC.
[0142] For purposes of illustration, a window 70 is cut through
first major side 50 of Schlemm's canal SC in FIG. 21. Through
window 70, an ocular implant can be seen residing in a lumen
defined by Schlemm's canal. The ocular implant shown in FIG. 21 is
ocular implant 300 shown in the previous figure. Ocular implant 300
comprises a body 302 including a plurality of spines and a
plurality of frames 306. The frames 306 of body 302 include a first
frame 306A, a second frame 306B and a third frame 306C. First frame
306A comprises a first landing surface 342A and a second landing
surface 342B. First landing surface 342A and second landing surface
342B define a first footprint line 338A. Second frame 306B
comprises a first landing surface 342C and a second landing surface
342D. First landing surface 342C and second landing surface 342D
define a second footprint line 338B. Third frame 306C comprises a
first landing surface 342E and a second landing surface 342F. First
landing surface 342E and second landing surface 342F define a third
footprint line 338C. In the embodiment of FIG. 21, first footprint
line 338A, second footprint line 338B, and third footprint line
338C intersect at an apex of a conical surface C. Due to page size
constraints, conical surface C is truncated in FIG. 21.
[0143] In the embodiment of FIG. 21, the landing surfaces of each
frame are configured to seat against the outer major side 50 of
Schlemm's canal SC. In the eye, the outer major side of Schlemm's
canal is backed by scleral tissue. Accordingly, in the exemplary
embodiment of FIG. 21, the landing surfaces of each frame will be
seated against and supported by scleral tissue of the eye. Normal
supporting forces will be applied to the landing surfaces of the
struts by the scleral tissue. Applicant has created ocular implants
designed to work in harmony with the dome shaped wall that defines
the anterior chamber of the human eye. In some useful embodiments,
the ocular implants are configured such that reaction forces
applied to the ocular implant by scleral tissue while the ocular
implant is being advanced into Schlemm's canal subject the ocular
implant to pure bending with little or no twisting. The ocular
implant may be configured such that a net twisting moment applied
to each spine by the normal forces supporting the landing surfaces
is substantially zero. The ocular implant may also be configured
such that the normal forces supporting the landing surfaces
primarily or exclusively act to bend each spine along the
preferential bending plane thereof. In some useful embodiments, the
preferential bending plane of each spine extends in a direction
that is at right angles to a conical surface defined by the ocular
implant.
[0144] While exemplary embodiments of the present invention have
been shown and described, modifications may be made, and it is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention.
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